Steri-Oss, Inc.: FDA clearances and approvals
Steri-Oss, Inc. has 46 FDA 510(k) clearances (first 1992, latest 1998), across 5 product codes in 2 review panels. Median 510(k) review time: 88 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 40 | 40 |
| EMA | Cement, Dental | 3 | 3 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| EMM | Chisel, Osteotome, Surgical | 1 | 1 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
Most recent Steri-Oss, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982400 | STERI-OSS' IMPROV TEMPORARY DENTAL CEMENT | EMA | 1998-09-23 | 75 |
| K980439 | REPLACE CYLINDRICAL IMPLANTS | DZE | 1998-03-16 | 40 |
| K973433 | STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT | DZE | 1997-12-05 | 86 |
| K973423 | STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT | DZE | 1997-12-05 | 86 |
| K973402 | STERI-OSS 3.25 MM REPLACE DENTAL IMPLANT SYSTEM | DZE | 1997-11-26 | 78 |
| K972965 | STERI-OSS UNTIL IMPLANT CEMENT | EMA | 1997-11-07 | 88 |
| K970073 | BIO-ESTHETIC INDIRECT ABUTMENT | NHA | 1997-07-03 | 176 |
| K964739 | STERI-OSS TIODIZED SCREW | DZE | 1997-03-31 | 125 |
| K964220 | REPLACE TITANIUM IMPLANT SYSTEM | DZE | 1997-03-05 | 134 |
| K963945 | STERI-OSS GOLD ATTACHMENT SYSTEM | DZE | 1997-02-11 | 132 |
36 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Steri-Oss, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Steri-Oss, Inc. have?
Steri-Oss, Inc. has 46 FDA 510(k) clearances (first 1992, latest 1998), across 5 product codes in 2 review panels.
How long does FDA take to clear Steri-Oss, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Steri-Oss, Inc.'s cleared 510(k)s is 88 days.
What devices does Steri-Oss, Inc. make?
Its most frequent FDA product codes are DZE (Implant, Endosseous, Root-Form, 40); EMA (Cement, Dental, 3); EHD (Unit, X-Ray, Extraoral With Timer, 1).
Has Steri-Oss, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Steri-Oss, Inc. Related entities may recall under other names.
Next steps
- See all 46 Steri-Oss, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Steri-Oss, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.